Medicinal Product Support in Vietnam End-to-End Medicinal Product Regulatory Support in Vietnam 

Medicinal Products Regulatory Support in Vietnam – Overview

Vietnam’s pharmaceutical market is rapidly expanding, driven by rising healthcare spending, growing demand for quality medicines, and government initiatives supporting pharmaceutical manufacturing and healthcare modernization.

The government is aligning Vietnam's pharmaceutical regulations with ASEAN and ICH standards, making the Vietnam drug approval process more transparent for global manufacturers. These developments are creating strong opportunities for Vietnam market access for pharmaceuticals and long-term industry growth.

Understanding the Vietnam Ministry of Health drug registration procedures and Drug Administration of Vietnam (DAV) requirements is essential for efficient drug registration in Vietnam and successful product commercialization.

Medicinal Product Classification in Vietnam

Under Circular No. 20/2017/TT-BYT, the Vietnam Ministry of Health (MOH) classifies medicines into Regulatory categories to ensure safe use and efficient drug registration in Vietnam.

1. Over-the-Counter (OTC) Drugs
Medicines are considered safe for self-medication without a prescription and are widely used for common conditions.

2. Prescription Drugs
Medicines requiring physician supervision due to potential risks or interactions. These products must undergo the Vietnam drug approval process and obtain Drug Administration of Vietnam (DAV) registration.

3. Traditional Herbal Medicines
Plant-based medicines are regulated under the Vietnam pharmaceutical regulations, requiring quality and safety evaluation through the Vietnam Ministry of Health drug registration procedures.

4. Controlled Drugs
Substances are strictly regulated due to potential dependence or misuse. Their production, distribution, and prescription are monitored by the Drug Administration of Vietnam (DAV).

Controlled drug categories include:

• Narcotic drugs
• Psychotropic drugs
• Precursor drugs
• Combined drugs

All regulated substances are listed in Appendices I–VI of Circular 20/2017/TT-BYT.

Medicinal Product Drug Registration & Approval

The Drug Administration of Vietnam (DAV) under the Ministry of Health oversees Vietnam pharmaceutical licensing, product approvals, and post-marketing monitoring.

Understanding the drug registration process in Vietnam is essential for companies planning Vietnam market access for pharmaceuticals.

Key Regulations

• Circular 12/2025/TT-BYT – Governs marketing authorization of Vietnam pharmaceuticals
• Circular 30/2025/TT-BYT – Defines drug quality and testing standards
• Decree 163/2025/ND-CP – Specifies procedures for Vietnam pharmaceutical licensing

Drug Registration Process

1. Product Classification
Medicines are classified as chemical drugs, biologics, vaccines, biosimilars, or herbal medicines, determining the pathway for Drug Administration of Vietnam (DAV) registration.

2. Local Marketing Authorization Holder (MAH)
Foreign manufacturers must appoint a Vietnam-based MAH to support drug registration in Vietnam and lifecycle compliance.

3. Dossier Preparation & Submission
Applications must follow the ACTD dossier Vietnam or ICH-CTD format and include:

• Administrative documentation (CPP, GMP certificates)
• Quality and CMC data
• Clinical and non-clinical evidence
• Labeling and packaging information
• Vietnam pharmacovigilance requirements and risk-management plans

Submissions are made through the Drug Administration of Vietnam (DAV) portal.

4. Scientific Evaluation
DAV evaluates product quality, safety, and efficacy as part of the Vietnam drug approval process.

5. Marketing Authorization Grant
Approved products receive Marketing Authorization Vietnam pharmaceuticals, typically valid for five years.

6. Renewal & Variations
Renewals and post-approval changes must comply with Vietnam pharmaceutical regulations and may require DAV review.

7. Pharmacovigilance & Lifecycle Management
Companies must maintain systems to meet Vietnam pharmacovigilance requirements, including adverse event reporting and post-marketing safety monitoring.

Typical Review Timeline

• 12–18 months under the standard review pathway
• Fees vary based on product type and dossier complexity

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